1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
2.The clinical characteristics of chronic pancreatitis in children
Yongli FANG ; Jie WU ; Feihong YU ; Jin ZHOU ; Guoli WANG ; Dexiu GUAN ; Xiumin QIN
Chinese Pediatric Emergency Medicine 2024;31(10):756-760
Objective:To analyze the etiology of chronic pancreatitis(CP) and evaluate the impact of different intervention methods on the prognosis.Methods:This is a retrospective analysis conducted on clinical data of pediatric patients with CP admitted to Beijing Children's Hospital between January 2010 and December 2023,including etiology,clinical manifestations,imaging data and treatments.Follow-up assessments included height,weight,complications occurrence,and long-term nutritional status evaluated by using Z scores.Results:A total of 98 patients with CP were included in the study,containing 51 males and 47 females,with an age range of 1.95 to 15.96 years (median 8.49 years).The etiological contained the gene mutation (39.8%,39/98) (involving PRSS1, SPINK1, CFTR),the anatomical abnormality (26/98,26.5%),idiopathic pancreatitis (33.7%,33/98).Predominant clinical manifestations included abdominal pain (79/98,79.6%),nausea/vomit(48/98,49.0%),chest tightness/chest pain (10/98,10.2%),with malnutrition (44/98,44.9%) and the serum amylase increased in some patients.Imaging findings revealed heterogeneous pancreatic echoes,dilated pancreatic ducts and pancreatic stones via abdominal ultrasound,and a full or atrophic pancreas with irregular margins,tortuous or dilated pancreatic ducts through abdominal magnetic resonance imaging.Compared with CP caused by other reasons,hereditdry CP had a higher rate of pancreatic morphological changes(100.0% vs.88.1%, P<0.05).By March 2024,follow-up showed all 98 patients underwent initial medical treatment,followed by surgical intervention in 13 cases,endoscopic retrograde cholangiopancreatography intervention in 51 cases,and no surgical or endoscopic intervention in 34 cases.Six children developed diabetes,six had reduced fecal pancreatic elastase-1 but without fat diarrhea.Long-term follow-up indicated improved nutritional status among children who underwent endoscopic retrograde cholangiopancreatography intervention(Z score,-1.22 vs.0.74, P<0.001). Conclusion:Gene mutations and anatomical abnormalities is the main etiological factors in pediatric patients with CP.Early endoscopic intervention can significantly improve the long-term prognosis of the children.
3.Clinical characteristics of eosinophilic esophagitis in children
Jing LI ; Jin ZHOU ; Jing GUO ; Yongli FANG ; Jie WU ; Tianyou WANG
Chinese Journal of Applied Clinical Pediatrics 2024;39(2):104-108
Objective:To summarize the clinical characteristics of eosinophilic esophagitis (EoE) in children.Methods:Clinical data of children with EoE who were hospitalized in the Department of Gastroenterology, Beijing Children′s Hospital, Capital Medical University from January 1, 2017, to December 31, 2022, were retrospectively analyzed.Results:A total of 18 children with EoE were included in the study, including 13 males and 5 females, with the age of 11.96 (4.96, 12.81) years.Vomiting was more common in preschool children (4/5), while abdominal pain was the main symptom in school-age and adolescent children (11/13). There were 22.22% (4/18) of the children with EoE had an increased white blood cell count, and 33.33%(6/18) had an increased eosinophil count.Allergic history in the first-degree relatives was detected in 55.56%(10/18) of the children with EoE.Total immunoglobulin E (IgE) level was elevated in 68.75% (11/16) of the children.Food-specific IgE was positive in 66.67% (12/18) of the children with EoE.Milk, eggs, and wheat were the most common allergens.Esophageal mucosal hyperemia and erythema, rough, erosion, linear ulcers, annular changes, furrow or wrinkled paper changes, granular changes, polypoid or relaxation of the cardia were seen under endoscopy, whereas 27.78% (5/18) of the children showed normal esophageal mucosa.The histopathology showed chronic inflammation of the esophagus and increased eosinophil count.Three patients were lost of follow-up, and the remaining 15 were followed up for 6-24 months.All children with EoE were treated with the elimination diet.Nine children treated with glucocorticoids experienced clinical remission in a short period of time, involving 1 case with recurrence after withdrawal and being effectively treated by hormone therapy, and 2 cases of repeated digestive system symptoms or increased eosinophil count after withdrawal and being effectively relieved by the elimination diet.Conclusions:EoE is more common in elderly children and boys.Vomiting is the main symptom in pre-school aged children, whereas abdominal pain is the main symptom in school-aged children and adolescents.Increased peripheral white blood cell count and eosinophil count can be detected in some cases, and most of them are positive for food allergen tests.Gastrointestinal endoscopy and histopathology are important in the diagnosis of EoE.Elimination diet may be effective in some patients.Glucocorticoids are of great significance in the treatment of EoE, but a few children are steroid-dependent.
4.Establishment and application of clinical pharmaceutical pathway of anti-infective treatment for high-risk populations of antibiotic-associated encephalopathy
Chunhui DU ; Yongli WAN ; Xiaojiao YANG ; Jin ZHOU ; Jianbo WANG ; Zhenyu ZHAO
China Pharmacy 2024;35(21):2690-2696
OBJECTIVE To establish a clinical pharmaceutical pathway of anti-infective therapy for high-risk populations of antibiotic-associated encephalopathy (AAE), and analyze its application effects. METHODS Clinical pharmacists developed the “AAE High-Risk Population Screening Form” and “Antibiotic AAE Risk Comparison Form” based on literature and expert opinions, and established the “Clinical Pharmaceutical Pathway of Anti-infective Treatment for AAE High-Risk Population” in our hospital. A prospective, non-randomized controlled study was conducted from May 2023 to April 2024, including 50 cases in the observation group and 50 cases in the control group among patients with pulmonary infections admitted to the Dept. of Internal Medicine in our hospital. The observation group was involved in the development of an anti-infective treatment following the clinical pharmaceutical pathway by clinical pharmacists, while the control group received routine anti-infective treatment by clinical physicians. The occurrence of AAE, the rational antibiotic drug use, and the effectiveness of initial anti-infective treatment in the two groups were observed, and the intervention measures and outcomes of AAE cases were summarized. RESULTS The anti-infective treatment clinical pharmaceutical pathway for AAE high-risk population was preliminarily established in our hospital. The analysis of the application effects showed that there was 1 case of AAE in the observation group and 8 cases in the control group, with a significantly lower incidence of AAE in the observation group than in the control group; the rational antibiotic drug use and the effectiveness of initial anti-infective treatment in the observation group were both significantly superior to those in the control group (P<0.05). Drug withdrawal and dressing change were the preferred effective intervention measures for AAE, and encephalopathy treatment drugs could be used as auxiliary measures for symptom relief. Timely and effective intervention was conducive to rapid symptom relief, with a total improvement rate of AAE of 88.89%. CONCLUSIONS The anti-infective treatment clinical pharmaceutical pathway for AAE high-risk population can effectively prevent the occurrence of AAE as well as contribute to promoting rational drug use and the effectiveness of initial anti-infection plans and strengthening treatment outcomes.
5.Construction and Teaching Reform for the Course of Solid Preparation Based on the Cultivation of High-quality Technical and Skilled Talents
Yinxiu JIN ; Lei SHI ; Xuefen TAO ; Minyun JIANG ; Yongli LIU
Chinese Journal of Modern Applied Pharmacy 2024;41(2):253-260
OBJECTIVE
To explore the course construction and teaching reform of solid preparation with the aim of cultivating high-quality technical and skilled talents.
METHODS
Teaching objectives were set according to the post requires of solid preparation. Examples from pharmaceutical companies were used and the teaching content was reorganized by integrating professional courses and certificates. School and enterprise cooperation was deepened, information-based and multi-scenario learning resources were built, and high-quality curriculum politics teaching resources were created. Professional education and ideological education, knowledge imparting and value guidance were fully integrated. Based on the project-driving method, the integration of "Theoretical-Virtual-Real" and online and offline blended teaching was carried out. The evaluation method was "three comprehensive evaluation".
RESULTS AND CONCLUSION
Through the practice of course construction and teaching reform, students’ grades significantly increased and their skills become proficient. Their recognition of their profession significantly improved, and their awareness of quality and responsibility was significantly enhanced. Good reform effects had been achieved.
6.Effects of dapagliflozin on inflammatory cytokines and cardiac function in elderly patients with preserved ejection fraction heart failure complicated with type 2 diabetes mellitus
Jianpei SU ; Yongli WANG ; Zhimin WANG ; Qi WU ; Jun GU ; Jin LI ; Bijuan LIANG
Journal of Clinical Medicine in Practice 2024;28(7):85-89
Objective To investigate the effects of dapagliflozin on inflammatory cytokines, blood glucose control and cardiac function in elderly with preserved ejection fraction heart failure (HFpEF) combined with type 2 diabetes. Methods A total of 80 elderly HFpEF patients with type 2 diabetes mellitus were randomly divided into control group (40 cases) and study group (40 cases). The control group received hypoglycemic and anti-heart failure standard therapy, and the study group received hypoglycemic and anti-heart failure standard therapy and dapagliflozin therapy. Both groups were treated for 6 months. The levels of inflammatory factors, blood glucose control, myocardial markers, exercise endurance [6 min walking distance (6MWD)], cardiac ultrasound related indexes and adverse drug reactions were compared between the two groups. Results After 6 months of treatment, serum interleukin-6 (IL-6), hypersensitive C-reactive protein (hs-CRP) and tumor necrosis factor (TNF)-α in the study group were significantly lower than those in the control group (
7.Effect of speech imagery therapy on dysarthria in children with cerebral palsy
Yongli WANG ; Xinchun YU ; Xinyue JIN ; Siyu BI ; Xi WANG ; Tianhao NI ; Qin WAN ; Zhaoming HUANG
Chinese Journal of Rehabilitation Theory and Practice 2023;29(5):601-607
ObjectiveTo investigate the effect of speech imagery therapy combined with traditional dysarthria training on dysarthria in children with cerebral palsy. MethodsFrom August to December, 2022, 21 children with cerebral palsy combined with dysarthria in Wuhu Fifth People's Hospital were randomly divided into three groups A, B and C. Group A was given traditional dysarthria training for 30 minutes everytime, group B was given implantable speech imagery combined with traditional dysarthria training for 40 minutes everytime, and group C was given additional speech imagery combined with traditional dysarthria training for 40 minutes everytime, five days a week, for three weeks. Articulation and Phonology Assessment Scale, Mouth Sensory-Motor Assessment Scale, and mandibular distance, tongue distance and vowel space area (VSA) were evaluated before and after treatment. ResultsThere was no significant difference in all the indexes among three groups before treatment (F < 1.247, P > 0.05). After treatment, the scores of phonological function and sensory-motor assessment scale increased (|t| > 2.575, P < 0.05), and the mandibular distance and VSA increased in groups A and B (|t| > 2.632, P < 0.05). The d-value of phonological function before and after treatment was more in groups B and C than in group A (P < 0.05), and no difference was found in the d-value of other indexes before and after treatment among three groups (P > 0.05). ConclusionBoth speech imagery therapies are effective in improving diction clarity, oral range of motion, and motion control ability in children with cerebral palsy, and are more effective in improving articulatory clarity than traditional speech-language training.
8.Preliminary study on double-balloon enteroscopy in the treatment of Peutz-Jeghers syndrome polyp with intussusception in children
Feihong YU ; Jing ZHANG ; Tianlu MEI ; Xiumin QIN ; Guoli WANG ; Jin ZHOU ; Yongli FANG ; Jie WU
Chinese Pediatric Emergency Medicine 2023;30(11):840-844
Objective:To assess the value of double-balloon enteroscopy(DBE)in the treatment of Peutz-Jeghers syndrome(PJS)polyp with intussusception in children.Methods:A total of 14 cases with PJS polyp with intussusception were collected in Gastroenterology Department of Beijing Children′s Hospital Affiliated to Capital Medical University from July 2019 to January 2023.The general information, clinical manifestations, history of surgeries, abdominal ultrasound, enteroscopy and postoperative outcomes were retrospectively analyzed.Results:Fourteen cases with intussusception of PJS(including nine boys and five girls) were enrolled, and the average age was(10.25±2.52)years.There were 21 small intestinal intussusceptions in 14 cases, including eight cases of single intussusception and six cases of multiple intussusceptions.All the patients underwent DBE examination and treatment.A total of 215 small intestinal polyps were removed, no direct complications such as bleeding or perforation were found during the operation.Twelve cases were confirmed intussusception relieved by DBE, and the average maximum diameter of polyps causing intussusception was(4.38±1.43)cm.In addition, DBE did not reach the site of intussusception polyp in one case, and another case developed intestinal obstruction after DBE operation, which were treated by surgery.Conclusion:DBE provides a relatively effective method for the treatment of PJS polyps with intussusception without complete ileus in children.
9.Dose-response relationship of alfentanil in combination with midazolam-etomidate inhibiting cardiovascular responses to laryngeal mask airway implantation in elderly patients
Fengdan MA ; Bowei JIANG ; Jiashuo ZHANG ; Jin HUANG ; Mingyu YANG ; Yang YANG ; Man WANG ; Yongli MA ; Na CHEN ; Chunguang WANG
Chinese Journal of Anesthesiology 2022;42(11):1306-1309
Objective:To evaluate the dose-response relationship of alfentanil in combination with midazolam-etomidate inhibiting cardiovascular responses to laryngeal mask airway implantation in elderly patients.Methods:American Society of Anesthesiologists Physical Status Ⅰ or Ⅱ patients of either sex, aged 65-85 yr, with body mass index of 20-30 kg/m 2, undergoing elective operation under general anesthesia, were enrolled in this study.Midazolam 0.025 mg/kg was intravenously injected for adequate sedation, 5 min later mean arterial pressure and heart rate were recorded for 3 consecutive times at 3-min interval, the mean value was collected and considered as the baseline value.Etomidate 0.2 mg/kg was intravenously injected, and alfentanil and rocuronium 0.6 mg/kg were intravenously injected when bispectral index value < 60.A laryngeal mask airway was inserted at 1.4 min after intravenous injection of alfentanil, and mechanical ventilation was performed.The dose of alfentanil was determined by the Dixon′s up-and-down method.The initial dose of alfentanil was set at 6.83 μg/kg.The dose of alfentanil in the next patient was determined according to the development of cardiovascular response to laryngeal mask airway placement.If the cardiovascular response to laryngeal mask airway placement occurred, the dose was increased for the next patient, and if cardiovascular response to laryngeal mask airway placement did not occur, the dose was decreased, and the ratio between the two successive doses was 1.0∶1.1.The cardiovascular response to laryngeal mask airway placement was defined as increase in maximum mean arterial pressure or maximum heart rate by≥20% of baseline values within 2 min after laryngeal mask airway placement.The median effective dose (ED 50), 95% effective dose (ED 95) and 95% confidence interval (95% CI) of alfentanil inhibiting cardiovascular responses to laryngeal mask airway placement in elderly patients were calculated by the Probit method. Results:When combined with midazolam and etomidate, the ED 50 (95% CI) of alfentanil inhibiting the cardiovascular responses to laryngeal mask airway placement in elderly patients were 5.605 (5.036-6.082) μg/kg, and the ED 95 (95% CI) were 6.625 (6.125-9.763) μg/kg. Conclusions:When combined with midazolam and etomidate, the ED 50 and ED 95 of alfentanil inhibiting the cardiovascular responses to laryngeal mask airway placement are 5.605 and 6.625 μg/kg, respectively, in elderly patients.
10.Reference value of lumbar spine bone mineral density and regional differences based on quantitative CT examination in healthy adult female in China
Ying JIN ; Kaiping ZHAO ; Jian QU ; Xia DU ; Yongli LI ; Shuang CHEN ; Yan WU ; Chunwei WU ; Guobin HONG ; Yong LU ; Yuqin ZHANG ; Xiao MA ; Jing LU ; Xigang XIAO ; Xiangyang GONG ; Zehong YANG ; Wei CHEN ; Miaomiao AN ; Ziyun WANG ; Siping NIE ; Lü YINGRU ; Jianbo GAO ; Shaolin LI ; Yuehua LI ; Qiang ZENG ; Xiaoguang CHENG ; Limei RAN
Chinese Journal of Health Management 2022;16(9):610-615
Objective:To establish the normal reference value of lumbar bone mineral density (BMD) under quantitative CT (QCT) in Chinese healthy adult females and to explore the regional differences.Methods:Total of 35 431 healthy women who met the inclusion criteria of Chinese health quantitative CT big data program were selected in this study. The BMD of the central plane of L 1 and L 2 vertebrae was measured by Mindways′s QCT system, and the mean value was taken. One-way analysis of variance was used to compare the BMD differences of lumbar vertebrae in women of different ages and regions. The subjects were grouped by an age interval of 10 years, and the level of BMD in different regions of the same age group were compaired. Results:The peak BMD of Chinese healthy adult women appeared in the age group of 20-29 years (Northeast China(183.01±24.58) mg/cm 3, North China (188.93±24.80) mg/cm 3, East China (187.54±27.71) mg/cm 3, South China (186.22±33.72) mg/cm 3, Central China (176.33±24.91) mg/cm 3, Southwest China(182.25±28.00) mg/cm 3), and then it decreased with age. The level of BMD in different regions decreased with the age. Before the age of 70 years, BMD in Central and Southwest China was always at a low level((176.23±24.91) to (90.38±28.12) mg/cm 3, 182.25±28.00 to (88.55±25.68) mg/cm 3), lower than those in Northeast China ((183.01±24.58) to (99.69±27.85) mg/cm 3), North China ((188.93±24.80) to (95.89±26.12) mg/cm 3), East China ((187.54±27.71) to (95.65±27.86) mg/cm 3). After 70 years of age, BMD tended to be the same in different regions ( P>0.05). The BMD values in Central China and Southwest China were similar in the age group of 40-60 years ( P>0.05). The BMD values in the health adult femles in the age group of 60 years in different regions of Chinawere all lower than those of bone mass abnormality (all P<0.05). The detection rate of osteoporosis in females over 50 years was the highest in Southwest China (25.65%) and it was the lowest in North China (17.30%). Conclusions:This study establishes reference values of BMD under QCT in healthy Chinese women, which can be used as a reference basis for identifying women with low BMD who are at risk of osteoporosis. The BMD value is the lowest in Southwest China and the highest in South China.


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